Systems and methods for decompression and elliptical traction of the cervical and thoracic spine

ABSTRACT

A traction device comprises a frame, a first bladder portion, a second bladder portion, a spacer, and a pump. The first bladder expands in an outward direction a distance greater than in a transverse direction. The second bladder expands in an angular direction. The second bladder is positioned generally below and to the side of the first bladder. Upon expanding in the outward direction, the first bladder bears against the back of the user&#39;s neck. Upon expanding in the transverse direction, the first bladder applies an angular traction to the cervical spine. Upon expanding in the angular direction, the second bladder bears angularly against the back of the user&#39;s upper thoracic region.

CROSS-REFERENCE TO RELATED APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication, are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND

1. Field of the Invention

Disclosed herein are spinal decompression and traction systems andmethods related to the field of spinal treatment. More particularly,certain embodiments disclosed herein relate to cervical and thoracicspinal decompression and traction systems having a plurality ofinflatable bladders and methods of use that maintain a normal lordoticcurve and counter hyper-kyphosis of the upper thoracic spine.

2. Description of the Related Art

Cervical pain is one of the most common health-related complaints. Whenthere are no neurological deficits, symptomatic relief of pain is oftensought with either non-steroidal analgesics, or various physical therapymodalities, including cervical traction. Most traction has consisted ofaxial linear distraction employing various head/chin straps and weightsof 20 to 25 pounds. Such traction tends to straighten the cervical spineand often results in TMJ pain.

The undamaged cervical spine normally defines a forward or lordoticcurve of about 43° (measured from C2-C7) whereby weight is distributedon hard individual bony articular surfaces in the posterior and softintervertebral discs to the anterior. Without such a forward curve inthe cervical spine, weight of the head transfers forward onto the softnon-bony intervertebral discs and vertebral bodies causing discs todehydrate, wear, degenerate and protrude into the anterior subarachnoidspace. As vertebral bodies bear uneven stress, spurs and osteophytesform. Additionally, individuals with lost or reversed (buckled) cervicalspinal curves eventually exhibit a significant loss of natural jointmovement, further limiting the normal canaliculus seepage and imbibitionof adjacent fluids via vertebral end plates and annuli. Without suchnutrient rich fluids the discs continue to dehydrate, further weakeningthe discs, resulting in a further loss of mobility, degeneration andpossible nerve damage. Active nutrient transport is particularlyimportant because the intervertebral discs' indigenous vascular supplyoften disappears at approximately 20 years of age.

Further, as the cervical spine is forced into flexion and the lordoticcurve is reversed, the dura, cord and nerve-roots are drawn out; theroot-sleeves come into contact with the pedicles, and the nerve rootswith the inner surfaces of the sleeves. During extension (lordotic curverecovery) the dura, cord and nerve-roots in the cervical canal areslack; the root-sleeves have lost contact with the pedicles and thenerve-roots with the inner surfaces of the sleeves.

Axial/Linear/Longitudinal traction has long been employed to decompresscervical joints of the spine. Typically the head is pulled, pried,lifted or otherwise separated from the thorax along the Y axis (+Y axistranslation or elevation translation). Ostensibly, to pry the jointsapart at the posterior, forward flexion (+X axis rotation) is oftenemployed in conjunction with or as an unavoidable component of lineartraction. Linear traction or elevation translation applied to a curvedcolumn decreases or removes the curve. Likewise, adding the component offlexion or + rotation about the X axis, would apply a buckling force tothe cervical spine and have the effect of reversing the curve (−Z axistranslation). These forces, powerful enough to separate the spinaljoints, are unfortunately antithetical to the natural geometry andbiomechanics of the human cervical spine. The anchor points commonlyused in Axial/Linear/Longitudinal traction are the head as it is pulledaway from the thorax and/or the trapezius muscles as the thorax ispushed away from the restrained head. U.S. Pat. No. 4,805,603 toCumberland describes a method where the head and thorax are separated bytwo platforms with an expanding air chamber between the two platforms.These methods, due to their linear function reduce, remove or reversethe proper cervical curve. U.S. Pat. No. 6,506,174 to Saunders alsodescribes a linear traction system.

Some alternatives to axial/linear/longitudinal traction for disc, jointand nerve decompression seek to maintain a normal lordotic curve. Forexample, U.S. Pat. Nos. 5,382,226; 5,569,176; 5,713,841; 5,906,586;7,060,085; 8,029,453; and D508,566S to Graham, each of which is herebyincorporated by reference herein in its entirety, disclose someembodiments of systems for decompression. In two IRB studies utilizingmultiple MRI's, an embodiment of the disclosed systems showed aconsistent ability to draw bulging disc material back toward the discproper and away from the subarachnoid space and spinal cord whilesimultaneously enhancing or restoring the cervical lordotic curve duringand after one 20 minute treatment. Patients reported immediatesymptomatic relief of cervical pain. However, there exists a need forimproved decompression systems that also address hyper-kyphosis of theupper thoracic spine.

SUMMARY

Described herein are some embodiments of decompression and tractionsystems that maintain a normal lordotic curve and counter hyper-kyphosisof the upper thoracic spine. Methods of assembling and using thedecompression and traction systems described herein are also included.These decompression and traction systems and related methods aredescribed in greater detail below.

One aspect of the present invention is the recognition thattraditionally available traction systems do not provide devices, systemsand methods that simultaneously address cervical lordotic curveloss/reversal (hypolordosis/kyphosis), and the often accompanyingposterior (−Z) translation (hyper-kyphosis) of the upper thoracic spine.Embodiments and methods described herein preferably provide pneumaticradial decompression and traction equipment for treatment of thecervical and thoracic spine including a free-standing frame, first andsecond expandable bladders, the first expandable bladder providingpositive pressure to support a cervical spinal portion in a normallordotic curve configuration, and the second expandable bladderproviding positive pressure to support a thoracic spinal portion in anormal curve configuration to counter hyper-kyphosis of the upperthoracic spine.

According to certain embodiments of the invention, devices, systems andmethods are described that simultaneously address cervical lordoticcurve loss/reversal (hypolordosis/kyphosis), and the often accompanyingposterior (−Z) translation (hyper-kyphosis) of the upper thoracic spine.

In relation to the head and neck, −Z translation of the upper thoracicspine is an integral part of anterior or “Forward Head Carriage.” As thehead shifts forward and/or the upper thoracic spine moves posterior, theweight of the head and neck, approximately 15 pounds, creates a forwardbuckling force (−Y and +Z combination) on the thoracic spine. Thiscontinuous forward and downward force begets more forward head carriageand more compressive action to the cervical and thoracic intervertebraldiscs and bodies. Many are familiar with the term “Dowagers Hump” wherehyper kyphosis of the thoracic spine is so pronounced as to be obviouswith the naked eye. While approximately 30% of these postural defects(especially in women) are said to be caused by anterior thoracicvertebral body fractures due to osteoporosis, most hyper-kyphoticpostures are developed over time by continuous anterior and downwardforce on the cervical and thoracic intervertebral discs and vertebralbodies.

As people spend long hours crouched in front of computer screens, wearheavy back packs, are involved whiplash type auto and sports injuries,forward head posture with associated cervical curve loss, and hyperthoracic kyphosis has become more prevalent. Neck and back pain, muscletension and spasm, headaches, neuropathies and degenerative vertebraljoint disease result from continuous cervical-thoracic disc and jointcompression. While there have been elastic bands and braces applied tothe spine to pull or hold it upright in an attempt to ameliorateworsening posture, results are mixed.

In some embodiments, the devices, systems and methods described hereinapply pneumatic forces directly to the offending spinal apexes inopposing directions. With the simultaneous application of two separateair cells the cervical spine is locked and powerfully decompressed intoits proper lordotic or curved configuration (<^>) with −Y +Z +Y forcevectors while the hyper kyphotic area of the upper thoracic spine issimultaneously decompressed with a combination +Z/−Y force mid-vector.The cervical spine's lordotic curve is powerfully decompressed andenhanced while the thoracic hyper-kyphosis is simultaneously reduced. Insome embodiments, a two pump system can be employed to alternate orunevenly inflate the air cells. In some embodiments, a complex multivectored air cell can be used in place of two individual cells. In someembodiments, the devices, systems and methods described herein use theentire cervical spine including the occiput (base of skull) as the 1stanchor point and the upper thoracic spine as the second point. The aircells can directly contact the cervical spine/occiput and the upper 25%of the thoracic spine.

According to one embodiment, a traction device comprises a frame, afirst bladder portion, a second bladder portion, a strap, and a pump.The first bladder expands in an outward direction a distance greaterthan in a transverse direction. The second bladder expands in an angulardirection. The second bladder is positioned generally below and to theside of the first bladder. The frame is secured to the user's head. Uponexpanding in the outward direction, the first bladder bears against theback of the user's neck and forces the cervical spine to curveforwardly. Upon expanding in the transverse direction, the first bladderapplies an angular traction to the cervical spine. Upon expanding in theangular direction, the second bladder bears angularly against the backof the user's upper thoracic region and forces the thoracic spine todecompress and reduces hyper-kyphosis of the upper thoracic spine.

In certain embodiments, a traction device for imparting a forward curveto the cervical spine and reducing hyper-kyphosis of the upper thoracicspine is provided. The device comprises a frame adapted to be supportedon a rigid support surface. The frame is configured to be disposed abouta user's head and neck and defines contact surfaces for abutting therigid support surface. The frame has a neck support extending betweenfirst and second side portions of the frame. A first inflatableelongated bladder is coupled to the neck support and configured to bepositioned below a neck of a user during use. The first inflatableelongated bladder is expandable in a first direction outwardly from theneck support toward the neck of a user and expandable in a seconddirection substantially normal to the first direction upon inflation. Asecond inflatable elongated bladder is coupled to the neck support andconfigured to be positioned below the upper thoracic region of a userduring use. The second inflatable elongated bladder is expandable in athird direction angularly from the neck support toward the upperthoracic spine of a user upon inflation. A securing strap is coupled tothe frame and configured to secure the frame to the user's head suchthat the first inflatable elongated bladder is disposed adjacent theback of the user's neck and transverses the cervical spine such that thefirst direction of expansion is toward and substantially normal to thecervical spine. The second inflatable elongated bladder is disposedadjacent the back of the user's upper thoracic region and transversesthe upper thoracic spine such that the third direction of expansion istoward and substantially normal to the upper thoracic spine. A pumpsystem is provided for selectively inflating and deflating the first andsecond inflatable elongated bladders. Upon the first inflatable bladderexpanding in the first direction, the first inflatable bladder bearsoutwardly against the back of the user's neck and forces the cervicalspine to curve forwardly. Upon expanding in the second direction, thefirst inflatable bladder applies an angular traction to the cervicalspine. Upon the second inflatable bladder expanding in the thirddirection, the second inflatable bladder bears angularly against theback of the user's upper thoracic region and forces the thoracic spineto decompress and reduces hyper-kyphosis of the upper thoracic spine.

In some embodiments, the traction device comprises a valve positioned incommunication with the pump system and the first and second inflatableelongated bladders. The valve comprises varying lumen diameters thatdirect flow between the pump system and the first and second inflatableelongated bladders. The first inflatable elongated bladder is pivotablycoupled to the neck support. A spacer is configured to be coupledbetween a portion of the frame and the second inflatable elongatedbladder to adjust the angulation of the second inflatable elongatedbladder during inflation.

In other embodiments, a traction device is provided for imparting aforward curve to the cervical spine and reducing hyper-kyphosis of theupper thoracic spine. The device comprises a frame having a transverseneck support projecting upwardly from first and second side portionsdefining a base of the frame. A first inflatable bladder portion iscoupled to the neck support. The first inflatable bladder portion isconfigured to expand in an outward direction from the neck support adistance greater than the expansion of the first inflatable bladderportion in a transverse direction normal thereto. A second inflatablebladder portion is coupled to the neck support. The second inflatablebladder portion is configured to expand in an angular direction from theneck support. The second inflatable bladder portion is positionedgenerally below and to the side relative to the first inflatable bladderportion. A strap is coupled to the frame and configured to secure theframe to the user's head such that the first inflatable bladder portionis disposed adjacent the back of the user's neck and transverses thecervical spine such that the outward direction of expansion is towardand substantially normal to the cervical spine. The second inflatablebladder portion is disposed adjacent the back of the user's upperthoracic region and transverses the upper thoracic spine such that theangular direction of expansion is toward and substantially normal to theupper thoracic spine. A pump system is provided for inflating the firstand second inflatable bladder portions. Upon the first inflatablebladder portion expanding in the outward direction, the first inflatablebladder portion bears outwardly against the back of the user's neck andforces the cervical spine to curve forwardly. Upon expanding in thetransverse direction, the first inflatable bladder portion applies anangular traction to the cervical spine. Upon the second inflatablebladder portion expanding in the angular direction, the secondinflatable bladder portion bears angularly against the back of theuser's upper thoracic region and forces the thoracic spine to decompressand reduces hyper-kyphosis of the upper thoracic spine.

In some embodiments, a method is provided for imparting a forward curveto the cervical spine and reducing hyper-kyphosis of the upper thoracicspine. The method comprises securing a traction device to a user's head.The traction device comprises a support frame having a transverse necksupport projecting upwardly from a base of the support frame and firstand second inflatable bladder portions coupled to the neck support. Thetraction device is secured to the user's head includes positioning thetraction device such that the first inflatable bladder portiontransverses the cervical spine, and such that the second inflatablebladder portion transverses the upper thoracic spine. The firstinflatable bladder portion is expanded in a direction outward from theneck support and toward and substantially normal to the cervical spineto force the cervical spine to curve forwardly. The first inflatablebladder portion is expanded in a transverse direction to apply anangular traction to the cervical spine. The second inflatable bladderportion is expanded in a direction toward and substantially normal tothe upper thoracic spine to force the upper thoracic spine to decompressand reduce hyper-kyphosis of the upper thoracic spine.

In certain embodiments, methods may comprise alternately inflating anddeflating the first and second bladder portions. Inflation and deflationof the first and second bladder portions can be repeated. The firstinflatable bladder portion can have a semi-ellipsoidal configurationupon inflation. The second inflatable bladder portion can have asemi-ellipsoidal configuration upon inflation. During inflation ordeflation, flow can be directed between the pump system and the bladderportion through a valve that comprises different lumen diameters toprovide particular flow to or from the first and second inflatablebladder portions. Methods can include pivoting the first inflatablebladder relative to the neck support and/or positioning a spacer betweena portion of the frame and the second inflatable bladder portion toadjust the angulation of the second inflatable bladder portion duringinflation.

In some embodiments, a traction device is provided for imparting aforward curve to the cervical spine and reducing hyper-kyphosis of theupper thoracic spine. The device comprises a frame adapted to besupported on a rigid support surface. The frame is configured to bedisposed about a user's head and neck and defines contact surfaces forabutting the rigid support surface. The frame has a neck supportextending between first and second side portions of the frame. A firstinflatable elongated bladder is coupled to the neck support andconfigured to be positioned below a neck of a user during use. The firstinflatable elongated bladder is expandable in a first directionoutwardly from the neck support toward the neck of a user and expandablein a second direction substantially normal to the first direction uponinflation. A second inflatable elongated bladder is coupled to the necksupport and configured to be positioned below the upper thoracic regionof a user during use. The second inflatable elongated bladder isexpandable in a third direction angularly from the neck support towardthe upper thoracic spine of a user upon inflation. A spacer isconfigured to be coupled between a portion of the frame and the secondinflatable elongated bladder to adjust the angulation of the secondinflatable elongated bladder during inflation. A pump system is providedfor selectively inflating and deflating the first and second inflatableelongated bladders. Upon the first inflatable bladder expanding in thefirst direction, the first inflatable bladder bears outwardly againstthe back of the user's neck, and upon expanding in the second direction,the first inflatable bladder applies an angular traction to the cervicalspine. Upon the second inflatable bladder expanding in the thirddirection, the second inflatable bladder bears angularly against theback of the user's upper thoracic region.

In certain embodiments, a traction device for imparting a forward curveto the cervical spine and reducing hyper-kyphosis of the upper thoracicspine comprises a frame having a transverse neck support projectingupwardly from first and second side portions defining a base of theframe. A first inflatable bladder portion is coupled to the necksupport, the first inflatable bladder portion is configured to expand inan outward direction from the neck support a distance greater than theexpansion of the first inflatable bladder portion in a transversedirection normal thereto. A second inflatable bladder portion is coupledto the neck support. The second inflatable bladder portion is configuredto expand in an angular direction from the neck support. The secondinflatable bladder portion is positioned generally below and to the siderelative to the first inflatable bladder portion. A spacer is configuredto be coupled between a portion of the frame and the second inflatablebladder portion to adjust the angulation of the second inflatablebladder portion during inflation. A pump system is provided forinflating the first and second inflatable bladder portions. Upon thefirst inflatable bladder portion expanding in the outward direction, thefirst inflatable bladder portion bears outwardly against the back of theuser's neck. Upon expanding in the transverse direction, the firstinflatable bladder portion applies an angular traction to the cervicalspine. Upon the second inflatable bladder portion expanding in theangular direction, the second inflatable bladder portion bears angularlyagainst the back of the user's upper thoracic region.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the secondinflatable bladder portion during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the second inflatable bladderportion can be used to impart lateral flexion traction. Additionally, insome cases a component or device need not be adjustable, for example, aspacer or other component could be provided on a traction device tocause the second inflatable bladder portion to consistently provide forlateral flexion traction on one side, while other systems can providefor lateral flexion traction on the other side. Additionally, whileadjustments made with the spacer may be rotational, other movements oradjustments can be made with other mechanisms and arrangements, such asby sliding, for example.

According to another implementation, a method of imparting a forwardcurve to the cervical spine and reducing hyper-kyphosis of the upperthoracic spine is provided. A traction device is secured to a user'shead. The traction device comprises a support frame having a transverseneck support projecting upwardly from a base of the support frame andfirst and second inflatable bladder portions coupled to the neck supportand a spacer coupled between a portion of the frame and the secondinflatable bladder portion to adjust the angulation of the secondinflatable bladder portion during inflation to provide lateral flexiontraction. Securing the traction device to the user's head includespositioning the traction device such that the first inflatable bladderportion transverses the cervical spine, and such that the secondinflatable bladder portion transverses the upper thoracic spine. Thefirst inflatable bladder portion is expanded in a direction outward fromthe neck support and toward and substantially normal to the cervicalspine to force the cervical spine to curve forwardly. The firstinflatable bladder portion is expanded in a transverse direction toapply an angular traction to the cervical spine. The second inflatablebladder portion is expanded in a direction toward the upper thoracicspine to provide lateral flexion traction. In some embodiments, thespacer is rotated to adjust the angulation of the second inflatablebladder portion.

These and other objects and advantages of the present disclosure willbecome readily apparent from the following detailed description taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a decompression andtraction system.

FIG. 2 is a perspective view of a portion of the system shown in FIG. 1.

FIG. 3 is a top view of a portion of the system shown in FIG. 1.

FIG. 4 is a side view of a portion of the system shown in FIG. 1.

FIG. 5 is a cross-sectional side view of a portion of the system shownin FIG. 1.

FIG. 6 is a perspective view of a valve component shown in thecross-sectional side view of FIG. 5.

FIG. 7 is a perspective view of a portion of the system shown in FIG. 1,showing a second inflatable bladder in an unassembled configuration.

FIG. 8 is a schematic view of another embodiment of a decompression andtraction system, showing mobile air cells comprising a first inflatablebladder being pivotably adjustable and showing a spacer componentconfigured to be selectively coupled to the frame to adjust a positionof a second inflatable bladder.

FIG. 9 is a perspective view of the spacer component shown in FIG. 8.

FIGS. 10A-F are illustrative views of a patient's spine in multipleconfigurations, including some embodiments of decompression and tractionsystems in use in deflated and inflated configurations.

FIG. 11 is a schematic top view of a patient positioned on anotherembodiment of a decompression and traction system, showing air cellscomprising first and second inflatable bladders and an adjustable spacercomponent configured to be selectively coupled to the frame to adjust aposition of the second inflatable bladder, in the shown configurationthe spacer component adjusts the position of the second inflatablebladder to provide an even distribution of force generally along a forcevector in the −Y and +Z plane.

FIG. 12 is a schematic top view of a patient and the embodiment of FIG.11, showing a configuration wherein the spacer component is moved toadjust the position of the second inflatable bladder to provide anuneven distribution of force on one side of the patient in that a forcevector is directed, for example, in a −Y, +Z, and −X direction.

FIG. 13 is a bottom view of the embodiment of FIG. 11, in the shownconfiguration the spacer component adjusts the position of the secondinflatable bladder to provide an even distribution of force generallyalong a force vector in the −Y and +Z plane.

FIG. 14 is a bottom view of the embodiment of FIG. 11, showing aconfiguration wherein the spacer component is moved to adjust theposition of the second inflatable bladder to provide an unevendistribution of force to a patient in that a force vector is directed,for example, in a −Y, +Z, and −X direction.

DETAILED DESCRIPTION

According to some preferred embodiments, the devices, systems andmethods described herein relate to a decompression and traction systemfor imparting the desired lordotic shape into the cervical region of thespine and counteracting hyper-kyphosis of the area of the upper thoracicspine. Some systems can be used to work the spine and surrounding tissueto promote fluid and cellular exchange in and around the intervertebraldiscs.

In some embodiments, the device comprises a frame, a first substantiallyellipsoidal inflatable bladder transversely in a neck support cradlecarried by the frame, a second inflatable bladder supported on the necksupport cradle carried by the frame and configured to provide a forcevector against the upper thoracic spine when inflated, one or morerestraining straps for securing the device to the user's head such thatthe first and second bladders are disposed against the back of the neckunder a stress point in the cervical spine and against thehyper-kyphotic upper thoracic spine, respectively. Controlled inflationof the bladders by the user by a hand-held pump causes a controlledlifting and a stretching of the cervical and thoracic spine. As thefirst bladder is inflated, the configuration of the first bladder causesthe first bladder to expand vertically and, to a lesser extent,transversely. The vertical expansion lifts the spine, creating a spinalapex while the transverse expansion of the bladder applies an angulartraction to the neck on both sides of the apex. As the second bladder isinflated, preferably simultaneously, the configuration of the secondbladder causes the second bladder to expand vertically and transversely.The vertical and transverse expansion lifts the spine and applies anangular traction to the thoracic region.

By controlling the inflation of the bladders, the user can control thelifting and stretching of the spine and incrementally increase themagnitude of spinal arc and decompression of the cervical and thoracicregions to his or her own tolerance. As the bladders are repetitivelyinflated to the tolerance of the user and deflated, the cervical spineis alternatively and actively forced from a lesser arc to a greater orhyper-lordotic arc and the hyper-kyphotic arc of the upper thoracicspine is simultaneously reduced and decompressed, thereby promotingnutrient transport to the intervertebral discs while simultaneouslyincreasing the cervical lordotic arc and decreasing the thoracichyper-kyphosis. These decompression and traction systems and relatedmethods are described in greater detail below.

Referring now to the drawings, as shown in FIGS. 1-5, according to oneembodiment, a traction device 110 comprises a frame 112, openings orslots 114 configured to receive one or more straps to restrain theforehead and/or chin of a user, a first inflatable air bladder 116, asecond inflatable air bladder 118, and an air pump assembly 120.

The frame 112 is preferably molded of a durable plastic material in atubular configuration so as to define a pair of side members 122 and 124curved and meeting at an apex 126, and a transverse neck support 128.The frame side members 122 and 124 preferably form a stable base. Theneck support 128 preferably comprises vertically extending portions 130and 132 which project upwardly from the side members 122 and 124respectively and project inwardly to define inwardly directed raisedlateral portions 134 and 136. A neck cradle 138 extends transverselybetween portions 134 and 136, spanning frame side members 122 and 124.In some embodiments, the frame can be provided with side members thatare not connected at an apex 126, such as in some embodiments where sidemembers are shorter.

The first and second air bladders 116 and 118 are preferably configuredfor inflation and simultaneous application of force to the cervical andthoracic spine, when the patient is in a treatment position, todecompressed the spine into its proper lordotic or curved configuration(<^>) with −Y +Z +Y force vectors being applied to the cervical spinewhile the hyper-kyphotic area of the upper thoracic spine issimultaneously decompressed with a combination +Z/−Y force mid-vector.The cervical spine's lordotic curve is powerfully decompressed andenhanced while the thoracic hyper-kyphosis is simultaneously reduced. Insome embodiments, the devices, systems and methods described herein usethe entire cervical spine including the occiput (base of skull) as the1st anchor point and the upper thoracic spine as the second point. Theair cells can directly contact the cervical spine/occiput and the upper25%-40% of the thoracic spine. The first and second inflatable bladders116, 118, are described in more detail below.

To provide selective inflation and deflation of the first and secondinflatable bladders 116, 118, a flexible air line 140 of the air pumpassembly 120 communicates the interior of the first and secondinflatable bladders 116, 118 with a hand-operated air pump 142. In otherembodiments an automated pump can be used. A pressure relief valve 144is preferably disposed between the air line 140 and pump 142. Air line140 preferably extends from the relief valve 144 through an opening inthe neck support 128 and communicates with the first and secondinflatable bladders 116, 118. In some embodiments, the air can becommunicated through openings formed in the underside or ends of thebladders. In some embodiments, a valve 146, such as a multi-directionalmetering valve, shown in FIGS. 5 and 6 for example, can be coupled withthe air line 140 and can direct air to the first and second inflatablebladders 116, 118. In some embodiments the valve 146 comprises differentlumen diameters to vary the air flow directed to the opposing tractionair cells of the first and second inflatable bladders 116, 118.Different valve components can be used to adjust the amount or flow ofair to the respective air cells. While air is an example fluid used inthe pneumatic decompression described herein, other suitable fluids canbe used to increase or decrease the volume of the bladders, includingusing liquids in some embodiments. In some embodiments, a two pumpsystem can be employed to alternate or unevenly inflate the air cells.In some embodiments, a single complex multi-vectored cell or bladder canbe used in place of two individual cells.

According to one embodiment, by way of example, a frame 112 of atraction device 110 defines a spacing of about nine inches between thecurved side members 122 and 124 at a wide portion with the side memberscoming together at the apex 126 of the frame. The frame 112 ispreferably between about 11 to 17 inches in length in some embodiments.The frame 112 preferably elevates the neck support 128 about 0.5 toabout 1.5 inches above the floor or surface. In such a configuration,the frame 112 preferably bears against the floor or surface during useand reduces the tendency of the frame to twist about its transverseaxis. The cradle 138 in neck support 128 preferably tapers from anelevation of about 3 inches above the floor proximate side members 122and 124 to a central elevation of about 2.5 inches.

The first expandable bladder 116 is preferably coupled to and carried bythe neck support 128 in the cradle 138 defined therein. The firstexpandable bladder 116 is preferably secured in place as will bedescribed further herein. The lateral portions 134 and 136 of necksupport 128 are preferably provided with oppositely facing recessesformed therein adjacent the lateral ends of cradle 138 for receiving theextended ends of the first expandable bladder 116 to facilitateretention and alignment of the bladder on the cradle 138.

According to some embodiments, the upper portion of the first expandablebladder 116 is of a generally semi-ellipsoidal configuration havingrelatively pointed ends similar to the upper half of a football bladder.In one preferred bladder configuration, the underside of the firstexpandable bladder 116 is formed with undercut portions so as to definea central depending portion. At least a portion of the cradle ispreferably configured to receive the underside of the first expandablebladder 116. Preferably, the first expandable bladder 116, wheninflated, will expand upwardly from the cradle 138 to a slightly greaterextent than in a transverse direction. Additionally, in someembodiments, provision of the depending portion on the underside of thebladder provides a cushioning effect under the apex of the expandedbladder which bears against the user's neck, making the device morecomfortable for the user. Thus, as the bladder is inflated under andagainst the user's neck, it expands vertically and transversely, liftingthe spine to create a spinal apex and applying an angular traction tothe neck on both sides of the spinal apex. The amount of tractionexerted in the vertical direction, however, will be somewhat greaterthan that exerted longitudinally to obtain the vertical lift necessaryto restore the normal lordotic shape to the cervical region of the spinewithout overly tractioning the neck longitudinally.

In some embodiments, the first inflatable bladder 116 is constructed ofan expandable material such as neoprene rubber, defines a length ofbetween about 8 to 10 inches, a height of about 3 to 4 inches in anuninflated state, and depending on the configuration of the bladder atransverse width of about 3 inches. In some embodiments, the bladder 116is constructed of a material that resists expansion. In someembodiments, the bladder 116 is constructed of a heat-sealable urethanewith 200 Denier nylon. The bladder 116 can comprise a cover of anysuitable material, including, for example, a neoprene material. Thesemi-ellipsoidal upper portion of the first inflatable bladder 116, wheninflated, defines a transverse arc of about 4 inches in length about thecenter of the bladder. It is to be understood that these dimensions areby way of example only and can be varied, as can the configuration ofthe frame, straps, and first and second bladders without departing fromthe spirit and scope of the invention. For example, in some embodimentsthe bladder 116 can have a length of between about 6 to 9 inches, aheight of about 2 to 3 inches in a deflated state, a height of about 3to 4 inches in an inflated state. In some embodiments a deflatedcircumference of the bladder is about 4 inches and an inflatedcircumference of the bladder is between about 7 and 8 inches. In aninflated configuration, the bladder 116 can be taller than it is wide,for example, it can be approximately 4 inches tall and approximately 3inches wide when inflated in some embodiments.

The second expandable bladder 118 is coupled to and carried by the necksupport 128. The second expandable bladder 118 is preferably adjustablein some embodiments to accommodate patient anatomy and align withdesired force vector directions as will be described further herein. Thelateral portions 134 and 136 of neck support 128 are preferablyconfigured with recesses formed therein for receiving the extended ends148, shown in FIG. 7, of the second expandable bladder 118 to facilitateretention and alignment of the bladder on the neck support 128.

According to some embodiments, the second expandable bladder 118 is of agenerally semi-ellipsoidal configuration having a relatively curvedportion upon inflation for engaging a portion of the thoracic spine.Preferably, the second expandable bladder 118, when inflated, willexpand about the same amount transversely and upwardly from the necksupport 128. In some embodiments, the second expandable bladder 118 wheninflated expands more transversely than upwardly. In some embodiments,the second expandable bladder 118 when inflated expands more upwardlythan transversely. Thus, as the second expandable bladder 118 isinflated under and against the user's thoracic spine, it expandstransversely and vertically, lifting the spine to counter hyper-kyphosisand applying an angular traction to the thoracic spine. The amount oftraction exerted in the longitudinal direction, preferably, will besimilar to the amount of lift exerted vertically to obtain the necessarydecompression and lift to restore the normal shape to the thoracicregion of the spine.

In some embodiments, the second inflatable bladder 118 is constructed ofan expandable material such as neoprene rubber, defines a length ofbetween about 8 to 10 inches, a height of about 3 to 4 inches in anuninflated state, and depending on the configuration of the bladder atransverse width of about 3 inches. In some embodiments, the bladder 118is constructed of a material that resists expansion. In someembodiments, the bladder 118 is constructed of a heat-sealable urethanewith 200 Denier nylon. The bladder 118 can comprise a cover of anysuitable material, including, for example, a neoprene material. Thesecond inflatable bladder 118, when inflated, defines a transverse arcof about 4 inches in length about the center of the bladder. It is to beunderstood that these dimensions are by way of example only and can bevaried without departing from the spirit and scope of the invention. Forexample, in some embodiments the bladder 118 can have a length of about9 inches where it is coupled to the frame, a length of between about 6and 7 inches where the bladder 118 contacts the patient. The bladder 118can have a height of about 3 to 4 inches. The bladder 118 can have acircumference of about 6 to 7 inches.

In some embodiments the bladders preferably have a finite shape andexpand while being filled until the bladders reach the finite shape.Once the bladder has been filled to the finite shape, the pressurerelease valve of the pump assembly allows for gas or fluid to escapefrom the system to maintain a desired pressure within the bladder. Thepressure release valve is preferably an automatic pressure releasevalve. The system preferably also comprises a manual release valve, suchas a push button release valve. The desired pressure is preferably heldat a proven clinical level. In some embodiments the pressure releasevalve is configured to maintain a pressure of about 8 psi. At a pressureof about 8 psi the system preferably provides over 50 pounds oftractional force. In some embodiments the tractional force preferably isbetween about 50 and 60 pounds of tractional force.

While the above described bladder configurations are preferred, it is tobe understood that other configurations of expandable bladders could beemployed in the present invention, either with or without an expansioncontrolling casing to provide the desired lifting and traction of theuser's neck and spine. Moreover, in some embodiments, mechanicallyexpandable components can be used in place of the first and secondbladders. Mechanically expandable components can be coupled to the frameand selectively expanded to applying force vectors to the cervical andthoracic spine in a manner similar to those produced by the expandablebladders as described herein. For example, in some embodiments anexpanding mechanical component within a cushioned cover can beselectively actuated to provide the desired force distribution.

In some embodiments, one or more of the first and second expandablebladders 116, 118 are of a tubular configuration and are disposed in anon-expandable casing, preferably constructed of a vinyl or othersuitable material. The casing is preferably formed in the abovedescribed generally ellipsoidal configurations. As the tubular bladderexpands upon inflation, the expansion is limited by the configuration ofthe casing to provide the desired increase in the vertical andtransverse directions.

In some embodiments, as shown in FIG. 8, the first expandable bladder116 is preferably rotatably secured to the neck support 128. The firstexpandable bladder 116 can be tilted in a forward position, a backwardposition, or maintained in a central position. In some embodiments, thebladder can be locked into a desired position. Providing a rotatablefirst expandable bladder 116 preferably provides mobility for the aircell to comfortably accommodate various spinal configurations. In someembodiments, the second expandable bladder 118 can be rotatably securedto the neck support 128.

In some embodiments, as shown in FIGS. 8 and 9, a spacer component 150is preferably configured to be selectively coupled to the frame 112 toadjust a position of a second inflatable bladder 118. The spacercomponent can be attached to the frame and can allow clinicians andusers to increase the negative Y directional component of the lower aircell. In one embodiment, the spacer component comprises an air cell orbladder engaging face 152, a notched connector portion 154 and opposingside portions 156. Other spacer configurations can be used to modify thedirectional component of the second inflatable bladder 118.

FIGS. 10A-F are illustrative views of a patient's spine in multipleconfigurations, including some embodiments of decompression and tractionsystems in use in deflated and inflated configurations. FIG. 10A shows apatient with cervical curve loss, forward head carriage, and disccompression. FIG. 10B shows a patient with normal spinal curves. FIGS.10C and 10D show a patient and one embodiment of a decompression system110 having a chin and forehead restraint, wherein the views show thedecompression system 110 in a deflated configuration and an inflatedconfiguration, respectively. FIGS. 10E and 10F show a patient andanother embodiment of a decompression system 110 having a foreheadrestraint, wherein the views show the decompression system 110 in adeflated configuration and an inflated configuration, respectively.

As shown in FIGS. 10C-F, restraint straps 158 and/or 160 can be securedat the ends thereof to one or more of slots 114. Straps can be passedunder the user's chin and over the user's forehead in some embodiments.In other embodiments, a strap can be passed over the user's foreheadonly. The straps can be secured and fastened in any suitable manner. Forexample, interlocking hook and loop type fasteners, snaps, buckles orother fasteners can be used. According to some embodiments, the tractiondevice 110 can be easily and securely affixed to the user's head with astrap configuration such that with the user lying flat on his or herback on a horizontal surface, the frame 112 rests on the surface and theneck support 128 is disposed under the user's neck and tapered ends 162of the frame side members 122, 124 are substantially adjacent the user'sshoulders and generally near the upper thoracic region. The tightness ofthe securement of the device 110 to the user's head can be readilyadjusted as needed by the securement straps 158, 160.

In some embodiments, the system preferably comprises a frame made ofvirgin acrylonitrile butadiene styrene (ABS) plastic material. ABS is anengineering thermoplastic that is advantageous due to its strength,toughness, chemical resistance, and ability to maintain necessarystiffness. The expandable air cells are preferably made of heat-sealableurethane with 200 Denier nylon. The expandable air cells preferably havea neoprene cover. The facial straps are preferably made of a durable andwaterproof neoprene material. The hand pump and tubing are preferablymade of rubber/plastic. Other embodiments can include differentmaterials.

According to some embodiments, the system is lightweight (for example,about 3 lbs), portable, easy to operate, requires no assembly, noweights, cables or ropes to set-up, comes with choice of ballistic nyloncarrying case or educational box, instruction page and instructionalDVD. In one embodiment, the device comprises a built-in frame, anexpanding elliptical air cell (with neoprene cover) that creates radialtractional force and thoracic decompressive force, a patient-controlledpneumatic hand pump with a push button release and automatic safetyvalve connected to approximately 30 inches of tubing, and one dualaction head restraint designed for patients who suffer with TMJ (doesnot aggravate temporomandibular joint), which comprises an adjustableforehead strap, and a removable chin strap (which is optional in someother embodiments).

Accordingly to one aspect disclosed herein, methods for pneumatic radialtraction can restore the cervical and thoracic spine to the properconfiguration. Pneumatic radial traction, also known in some embodimentsas expanding ellipsoidal decompression (EED), is a process in whichjoints of the cervical spine are pneumatically tractioned andsimultaneously aligned into the cervical spine's proper radial or curvedconfiguration. A major clinical difference between some embodiments of apneumatic radial traction device disclosed herein and some prior artdevices is that the prior art devices flatten or reverse the propercervical curve to attain joint separation. In some embodiments, apneumatic radial traction device enhances or maintains the propercervical curve while attaining over twice the joint separation as someprior art devices.

With reference to FIGS. 10A and 10B, in the upright position, thecervical “lordotic” curve is what allows the weight of the head (10-15lbs.) to be directed toward the hard boney posterior articular surfacesof the neck rather than toward the softer anterior discs as in thecompressed neck. Through modern healthcare imaging it can be seen thatthat loss of the normal forward cervical curve) (approx. 43° and theresulting anterior disc compression this causes, was a contributingfactor in osteophyte formation (Wolff's Law), posterior disc bulging,disc herniation, disc degeneration, neck pain and loss in cervical rangeof motion.

With reference to FIGS. 10C to 10F, pneumatic radial traction separatesand simultaneously aligns the spinal joints in a curved or radialconfiguration. In some embodiments, an elliptical air cell directsmulti-vectored expansive forces from within the posterior spinalconcavity (back of neck), vertically (+Z axis translation) and in bothhorizontal directions. The spine is simultaneously tractioned in threemain directions. The radial configuration created by thesemulti-vectored forces produces high level joint separation at theposterior, middle and anterior of the disc while forcefully enhancingthe cervical spine's proper curve, rather than flattening or reversingthe curve. Pneumatic radial traction is preferably achieved when thejoints are separated by a vertical displacement greater than thehorizontal displacement, however, displacement of equal height and widthis also advantageous in some embodiments. An advantage of a pneumaticradial traction device is that it does not flatten or reverse the propercervical curve while attaining joint separation. In some embodiments,the system provides a traction device with multiple fulcrums. Forexample, at least two fulcrums are provided to provide treatment to thecervical and thoracic spine of the patient.

As the head is stabilized in the cervical device, joints are activelytractioned in 3 main directions instead of one or two. The cervicalspine is tractioned vertically along the +Z axis with a pneumatic forceof over 58 lbs. This force expands into and against the posteriorcervical concavity. Simultaneously the spine is tractioned horizontallyin the two traditional directions (+Y and −Y) with a pneumatic force ofover 40-lbs in each direction. These forces expand against the occiputand against the upper thoracic region. The combination of thesesimultaneously applied pneumatic forces produce radial traction. Whenfully inflated the elliptical pneumatic cell expands to a 7.5 inchradius, affecting the entire cervical spine. High level joint tractionoccurs at the posterior, center and anterior aspect of the vertebralbodies in a ratio coinciding with the discs' natural wedged spacing.While the pneumatic radial traction device separates the posterior ofthe joints to a magnitude typical of traditional traction, it separatesthe overall disc more than twice as much as linear traction.

With the simultaneous application of two separate air cells the cervicalspine is decompressed into its proper lordotic or curved configuration(<^>) with −Y +Z +Y force vectors while the hyper kyphotic area of theupper thoracic spine is simultaneously decompressed with a combination+Z/−Y force mid-vector. The cervical spine's lordotic curve ispowerfully decompressed and enhanced while the thoracic hyper-kyphosisis simultaneously reduced.

Continuous expansion and contraction of the air cells can be employed tocreate alternating hydration and milking of the intervertebral discs,activating their sponge-like imbibition action. Holding the air pressureconstant over a period of 15 to 20 minutes has the effect ofsimultaneously molding the spine into a curved or elliptical shape,decompressing discs and relaxing the dura, cord and nerve-roots in thecervical canal.

Embodiments described herein are preferably prescribed for patients withchronic neck pain due to a musculoskeletal or neurological impairment.The system applies radial tractional force to the cervical spine,enhancing the cervical lordotic curve while achieving high level jointseparation at the anterior, center and posterior aspect of the vertebralbodies and discs in a ratio corresponding with their natural wedgedspacing, reducing disc protrusions, compression and increasing range ofmotion. In some applications, devices advantageously decrease pain inchronic neck pain patients, decrease headaches and increase range ofmotion while reducing the necessity for chronic pain medication and necksurgery.

With continued reference to FIGS. 10A-10F, according to some embodimentsin use, the traction device 110 rests on a horizontal surface such thatthe neck support 128 projects upwardly therefrom. The user lies on thedevice in a prone position such that the back of the neck rests on thedeflated first expandable bladder 116 carried in the cradle 138 of theneck support 128. The deflated second expandable bladder 118 ispositioned between the neck support 128 and portions of the thoracicspine of the user. The chin and/or forehead restraining restraint strapsare respectively extended under the user's chin and/or about the user'sforehead and secured, thereby affixing the traction device 110 to theuser such that the neck and cervical spine extend over the neck supportand first expandable bladder 116 and the thoracic spine is adjacent thesecond expandable bladder 118. According to one preferred embodiment,the outward extension of the neck support 128 is relatively slight sothat when the bladder is in the deflated position with the forehead andchin restraints secured, very little or no force is exerted on the neckby the neck support. This is achieved by elevating the neck support 128above the frame such that the neck cradle 138 formed therein is about 2to 3 inches above the floor or other horizontal surface on which thedevice 110 is used. The first expandable bladder 116 is sized such thatupon full inflation, the apex of the curved upper surface of the bladderwill extend about 5 inches above the floor or surface. The secondexpandable bladder 118 is sized such that upon full inflation, a surfaceof the second expandable bladder engaging the thoracic spine will extendtoward the thoracic spine about 2 to 3 inches in the −Y/+Z direction.

In some embodiments, as the user slowly inflates the first and secondinflatable bladders 116, 118 using the air pump 142, the firstinflatable bladder 116 expands upwardly and, to a lesser extent,transversely, thereby forcing the cervical spine forwardly creating aspinal apex while concurrently stretching the spine angularly along bothsides of the formed spinal apex. The second inflatable bladder 118expands transversely in the −Y direction, thereby forcing the thoracicspine forwardly to offset the effects of hyper-khyphosis. The user thencontinues to inflate the first and second bladders 116 and 118 until hisor her individual tolerance level is reached. The bladders are thendeflated by use of the one way valve 144. The process is preferablyrepeated several times, slowly increasing the spinal arc in the cervicalregion and placing pressure on the thoracic region as the level oftolerance increases. In addition, the first and second bladders 116 and118 can be held in an inflated state at or slightly below the level oftolerance for varying periods of time up to ten to twenty minutes.Through such repetition, the cervical spine, thoracic spine andsurrounding tissue receive a workout promoting cellular exchange in andaround the intervertebral disc and a forward curve is reinstated intothe cervical spine while achieving proper spine configuration in thethoracic region. FIGS. 10A-10F illustrate the effects of the tractionand exercise devices 110 of some embodiments on the cervical andthoracic spine.

With reference to FIGS. 11-14, an adjustable spacer component 150 can beprovided in some implementations of a traction system 110 to provide forlateral flexion traction. For example, FIG. 11 is a schematic top viewof a patient positioned on another embodiment of a decompression andtraction system, showing air cells comprising first and secondinflatable bladders 116, 118 and an adjustable wedge-shaped spacercomponent 150 configured to be selectively coupled to the frame toadjust a position of the second inflatable bladder, in the shownconfiguration the spacer component is in a vertical orientation andadjusts the position of the second inflatable bladder to provide an evendistribution of force generally along a force vector in the −Y and +Zplane without providing any lateral flexion traction to the patient.

FIG. 12 shows a configuration wherein the spacer component is moved toadjust the position of the second inflatable bladder to provide anuneven distribution of force on one side of the patient in that a forcevector is directed, for example, in a −Y, +Z, and −X direction. Forexample, the spacer component is turned or rotated to a horizontalposition, whereby the wedge shape of the spacer contacts the secondinflatable bladder and causes the bladder to deflect in one lateraldirection more than another lateral direction. As shown, the spacer isplaced in right horizontal position and causes more deflection on theright side of the patient. In other configurations, the spacer can bepositioned in a left horizontal position to cause more deflection on theleft side of the patient. Based on the positioning of the spacer, thesecond bladder can expand in an angular direction. Turning the spacercomponent sideways creates lateral flexion traction by forcing theshoulder/trapezius down while the head is held in traction.

FIG. 13 is a bottom view of the embodiment of FIG. 11 and shows thespacer component in a vertical position that adjusts the position of thesecond inflatable bladder to provide an even distribution of forcegenerally along a force vector in the −Y and +Z plane, but does notdirect force laterally in a −X or +X direction. FIG. 14 is a bottom viewof the embodiment of FIG. 11, showing a configuration wherein the spacercomponent is moved to adjust the position of the second inflatablebladder to provide an uneven distribution of force to a patient in thata force vector is directed, for example, in a −Y, +Z, and −X directionas described in connection with FIG. 12. The lower linear displacementair cell is adjusted with a rotating wedge shaped spacer component,allowing clinicians to increase the angle and force of the mid (−Y)/(+Z)vector of this air cell. When adjusted to the right or left horizontalposition, the rotating wedge allows clinicians to unilaterally increaseand rotate the (−Y) directional component on either the right or leftside (+/−X) of the upper thoracic region, producing lateral flexiontraction. The rotating wedge shaped spacer component can be removed insome implementations to accommodate extreme kyphotic thoracic spines.

The various devices, systems and methods described above provide anumber of ways to carry out some preferred embodiments of the invention.Of course, it is to be understood that not necessarily all objectives oradvantages described may be achieved in accordance with any particularembodiment described herein. Thus, for example, those skilled in the artwill recognize that the devices and systems may be made and the methodsmay be performed in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otherobjectives or advantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. Similarly, the variouscomponents, features and steps discussed above, as well as other knownequivalents for each such component, feature or step, can be mixed andmatched by one of ordinary skill in this art to make devices and systemsand perform methods in accordance with principles described herein.

Although the invention has been disclosed in the context of someembodiments and examples, it will be understood by those skilled in theart that the invention extends beyond these specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof. Accordingly, the invention is notintended to be limited by the specific disclosures of preferredembodiments herein.

What is claimed is:
 1. A traction device for imparting a forward curveto the cervical spine and reducing hyper-kyphosis of the upper thoracicspine, the device comprising: a frame adapted to be supported on a rigidsupport surface, the frame configured to be disposed about a user's headand neck and defining contact surfaces for abutting the rigid supportsurface, the frame having a neck support extending between first andsecond side portions of the frame; a first inflatable elongated bladdercoupled to the neck support and configured to be positioned below a neckof a user during use, the first inflatable elongated bladder beingexpandable in a first direction outwardly from the neck support towardthe neck of a user and expandable in a second direction substantiallynormal to the first direction upon inflation; a second inflatableelongated bladder coupled to the neck support and configured to bepositioned below the upper thoracic region of a user during use, thesecond inflatable elongated bladder being expandable in a thirddirection angularly from the neck support toward the upper thoracicspine of a user upon inflation; a spacer configured to be coupledbetween a portion of the frame and the second inflatable elongatedbladder to adjust the angulation of the second inflatable elongatedbladder during inflation; and a pump system for selectively inflatingand deflating the first and second inflatable elongated bladders,whereby upon the first inflatable bladder expanding in the firstdirection, the first inflatable bladder bears outwardly against the backof the user's neck, and upon expanding in the second direction, thefirst inflatable bladder applies an angular traction to the cervicalspine and, whereby upon the second inflatable bladder expanding in thethird direction, the second inflatable bladder bears angularly againstthe back of the user's upper thoracic region.
 2. The device of claim 1,wherein the spacer is a wedge-shaped spacer.
 3. The device of claim 1,wherein the spacer is rotatable.
 4. The device of claim 1, wherein thespacer in a horizontal position is configured to adjust the angulationof the second inflatable elongated bladder during inflation to providelateral flexion traction.
 5. The device of claim 1, wherein the firstinflatable elongated bladder is pivotably coupled to the neck support.6. The device of claim 1, comprising a securing strap coupled to theframe and configured to secure the frame to the user's head such thatthe first inflatable elongated bladder is disposed adjacent the back ofthe user's neck and transverses the cervical spine such that the firstdirection of expansion is toward the cervical spine, and such that thesecond inflatable elongated bladder is disposed adjacent the back of theuser's upper thoracic region and transverses the upper thoracic spinesuch that the third direction of expansion is toward the upper thoracicspine.
 7. A traction device for imparting a forward curve to thecervical spine and reducing hyper-kyphosis of the upper thoracic spine,the device comprising: a frame having a transverse neck supportprojecting upwardly from first and second side portions defining a baseof the frame; a first inflatable bladder portion coupled to the necksupport, the first inflatable bladder portion configured to expand in anoutward direction from the neck support a distance greater than theexpansion of the first inflatable bladder portion in a transversedirection normal thereto; a second inflatable bladder portion coupled tothe neck support, the second inflatable bladder portion configured toexpand in an angular direction from the neck support, the secondinflatable bladder portion being positioned generally below and to theside relative to the first inflatable bladder portion; a spacerconfigured to be coupled between a portion of the frame and the secondinflatable bladder portion to adjust the angulation of the secondinflatable bladder portion during inflation; and a pump system forinflating the first and second inflatable bladder portions, whereby uponthe first inflatable bladder portion expanding in the outward direction,the first inflatable bladder portion bears outwardly against the back ofthe user's neck, and upon expanding in the transverse direction, thefirst inflatable bladder portion applies an angular traction to thecervical spine and, whereby upon the second inflatable bladder portionexpanding in the angular direction, the second inflatable bladderportion bears angularly against the back of the user's upper thoracicregion.
 8. The device of claim 7, wherein the spacer is a wedge-shapedspacer.
 9. The device of claim 7, wherein the spacer is rotatable. 10.The device of claim 7, wherein the spacer in a horizontal position isconfigured to adjust the angulation of the second inflatable bladderportion during inflation to provide lateral flexion traction.
 11. Thedevice of claim 7, wherein the first inflatable bladder portion ispivotably coupled to the neck support.
 12. The device of claim 7,comprising a strap coupled to the frame and configured to secure theframe to the user's head such that the first inflatable bladder portionis disposed adjacent the back of the user's neck and transverses thecervical spine such that the outward direction of expansion is towardthe cervical spine, and such that the second inflatable bladder portionis disposed adjacent the back of the user's upper thoracic region andtransverses the upper thoracic spine such that the angular direction ofexpansion is toward the upper thoracic spine.
 13. A method of impartinga forward curve to the cervical spine and reducing hyper-kyphosis of theupper thoracic spine, the method comprising the steps of: securing atraction device to a user's head, the traction device comprising asupport frame having a transverse neck support projecting upwardly froma base of the support frame and first and second inflatable bladderportions coupled to the neck support and a spacer coupled between aportion of the frame and the second inflatable bladder portion to adjustthe angulation of the second inflatable bladder portion during inflationto provide lateral flexion traction, wherein securing the tractiondevice to the user's head includes positioning the traction device suchthat the first inflatable bladder portion transverses the cervicalspine, and such that the second inflatable bladder portion transversesthe upper thoracic spine; expanding the first inflatable bladder portionin a direction outward from the neck support and toward andsubstantially normal to the cervical spine to force the cervical spineto curve forwardly, expanding the first inflatable bladder portion in atransverse direction to apply an angular traction to the cervical spine;and expanding the second inflatable bladder portion in a directiontoward the upper thoracic spine to provide lateral flexion traction. 14.The method of claim 13, comprising the step of alternately inflating anddeflating the first and second bladder portions.
 15. The method of claim14, comprising the step of repeating inflation and deflation of thefirst and second bladder portions.
 16. The method of claim 13, whereinthe first inflatable bladder portion has a semi-ellipsoidalconfiguration upon inflation.
 17. The method of claim 13, wherein thesecond inflatable bladder portion has a semi-ellipsoidal configurationupon inflation.
 18. The method of claim 13, wherein the traction devicecomprises a valve positioned in communication with a pump system and thefirst and second inflatable bladder portions, wherein the valvecomprises different lumen diameters, and directing flow from the pumpsystem through the valve to the first and second inflatable bladderportions.
 19. The method of claim 13, wherein the first inflatablebladder portion is pivotably coupled to the neck support, and pivotingthe first inflatable bladder relative to the neck support.
 20. Themethod of claim 13, comprising the step of rotating the spacer to adjustthe angulation of the second inflatable bladder portion.